Assessment of genotoxicity of herbal substances/preparations

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Current effective version

Adopted guideline

Reference numberEMEA/HMPC/107079/07
Effective from01/12/2008
KeywordsHerbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, genotoxicity testing
DescriptionThis document addresses the selection of materials for genotoxicity testing in support of applications for traditional herbal medicinal products/ herbal medicinal products.

Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2008–present


Published: 18/01/2010


Published: 08/01/2009


Published: 15/07/2008

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